AEterna Zentaris' Partner, Spectrum, Discloses Detailed Phase 2 Data for Ozarelix, in BPH at Annual AUA Meeting
May 23 2007 - 8:00AM
PR Newswire (US)
Ozarelix improved LUTS symptoms and urine flow over 28-week period
QUEBEC CITY, May 23 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc.
(TSX: AEZ; NASDAQ: AEZS), a global biopharmaceutical company
focused on endocrine therapy and oncology, today announced that its
partner Spectrum Pharmaceuticals (NASDAQ:SPPI) presented an
abstract outlining detailed Phase 2 results for AEterna Zentaris'
fourth-generation luteinizing hormone-releasing hormone (LHRH/GnRH)
antagonist, ozarelix, in benign prostatic hyperplasia (BPH).
Results indicate that ozarelix was well tolerated and demonstrated
statistically significant as well as clinically meaningful efficacy
in the treatment of lower urinary tract symptoms (LUTS) secondary
to BPH. Results also showed no statistically significant impact on
quality of life or erectile function. The abstract was presented
yesterday afternoon at the American Urological Association (AUA)
Annual Meeting being held this week at the Anaheim Convention
Center in Anaheim, California. "We are encouraged by these data
with ozarelix and look forward to seeing further results from the
fully-enrolled Phase 2b trial, said David J. Mazzo, Ph.D.,
President and CEO of AEterna Zentaris. "With cetrorelix in an
ongoing Phase 3 program and ozarelix completing a Phase 2b trial
this year, we are fortunate to be leading the LHRH antagonist class
with two very promising compounds for the treatment of BPH."
Details The abstract #93629 (Poster #1552) titled, "The efficacy
and safety of ozarelix, a novel GnRH antagonist in men with lower
urinary tract symptoms (LUTS) due to benign prostatic hyperplasia
(BPH)" reviewed results of a randomized, double-blind,
placebo-controlled, multi-center, dose-ranging Phase 2 trial in
BPH. Ozarelix was given intramuscularly (IM) to men with moderate
to severe LUTS due to BPH, to assess the compound's efficacy and
safety. Eligible patients were treated with placebo for 4 weeks to
establish baseline International Prostate Symptom Score (IPSS) and
uroflow values. Afterwards, 144 patients meeting the inclusion
criteria were randomly allocated to one of five treatment groups
with the following dosage regimens: - Placebo; - Ozarelix 5 mg on
Day 1 + 5 mg on Day 15; - Ozarelix 10 mg on Day 1 +10 mg on Day 15;
- Ozarelix 15 mg on Day 1 + 15 mg on Day 15; or - Ozarelix 20 mg on
Day 1 only. Patients were followed for 28 weeks. The primary
efficacy endpoint was change in IPSS at week 12 compared to
baseline. Secondary efficacy endpoints included changes in IPSS,
Quality of Life (QoL), patients with >= 30% and >= 40%
improvement in IPSS, uroflow values (Qmax), postvoid residual (PVR)
urine volume and prostate volume. Safety analysis included changes
in sexual function (IIEF-5), treatment of emergent adverse events
(AEs), lab values (including testosterone (T), PSA) and vital
signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, Qmax 9.7
mL/sec. and prostate size (cm(3)) 41.6 at baseline. Results The
effects developed rapidly, with noticeable activity at four weeks
from starting treatment, were maximal at 12-16 weeks, and persisted
for the 6 month observation period. At week 12, all
ozarelix-treated groups showed improvement with the greatest
improvement in the 15 mg + 15 mg group. Change from baseline in
IPSS was 8.6 (p